Improving Quality of Colonoscopy Using a 3D-imager

August 17, 2011 updated by: Sorlandet Hospital HF

Magnetic Endoscopic Imaging Versus Standard Colonoscopy in a Routine Colonoscopy Setting: A Randomised Controlled Trial

Coloscopy may be a painful procedure for the patient. This is due to a loop-formation of the coloscope. A 3D-real time imager produced by Olympus creates a real-time image of the scope while a traditional fluoroscopy device will only show instant pictures. We want to investigate whether the 3D-imager causes the patient less pain and is more time consuming than ordinary fluoroscopy

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Results published in Holme et.al. Gastrointestinal Endoscopy 2011;73:1215-1222.

Study Type

Interventional

Enrollment (Actual)

800

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Kristiansand, Norway
        • Sorlandet sykehus HF

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients referred for coloscopy on an out-patient basis

Exclusion Criteria:

  • Pregnancy
  • Pacemaker
  • Lack of ability to understand information given
  • Prior resection of the colon/rectum
  • Demanding analgetics prior to start of procedure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
pain during coloscopy
Time Frame: instant
instant
Time used to reach the coecum
Time Frame: instant
instant

Secondary Outcome Measures

Outcome Measure
Time Frame
coecum-intubation rate
Time Frame: instant
instant
level achieved when the coecum can not be reached
Time Frame: instant
instant
Need for assistance by a colleague
Time Frame: instant
instant
Need for analgetics
Time Frame: instant
instant
Pain during the first 24 hours after coloscopy
Time Frame: 24 hours
24 hours
Polyp detection rate
Time Frame: instant
instant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sorlandet Hospital HF

Investigators

  • Study Director: Geir S Hoff, PhD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (ACTUAL)

August 1, 2010

Study Completion (ACTUAL)

August 1, 2010

Study Registration Dates

First Submitted

August 21, 2007

First Submitted That Met QC Criteria

August 21, 2007

First Posted (ESTIMATE)

August 22, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

August 18, 2011

Last Update Submitted That Met QC Criteria

August 17, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SSHF-Colon-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain During Colonoscopy

Clinical Trials on 3D-imager

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Thailand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe